This is a non-randomized, open-label study of a fixed dose combination (FDC) of elbasvir (50 mg) and grazoprevir (100 mg) (EBR/GZR or MK-5172A) in participants with chronic hepatitis C virus (HCV) genotype 1 (GT1) infection with advanced fibrosis with and without human immunodeficiency virus (HIV) co-infection. All participants will be either HCV treatment naïve (TN) or treatment experienced (TE).
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
A single FDC tablet containing grazoprevir 100 mg + elbasvir 50 mg taken once daily by mouth.
Percentage of participants achieving sustained virologic response (SVR) 12 weeks after the end of all study therapy (SVR12)
SVR12 will be declared when a participant has HCV ribonucleic acid (RNA) \< lower limit of quantification (LLOQ) 12 weeks after the end of all study therapy. Levels of HCV RNA will be determined with the Roche COBAS® AmpliPrep/COBAS® TaqMan® HCV Test, v2.0, which has a LLoQ of 15 IU/mL.
Time frame: Week 24 (12 weeks after completing study therapy)
Percentage of participants experiencing an adverse event (AE)
An AE is defined as any untoward medical occurrence in a clinical investigation participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
Time frame: Up to 14 weeks
Percentage of participants withdrawing from study therapy due to an AE
An AE is defined as any untoward medical occurrence in a clinical investigation participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
Time frame: Up to 12 weeks
Percentage of participants achieving SVR 24 weeks after the end of all study therapy (SVR24)
SVR24 will be declared when a participant has HCV RNA \< LLOQ 24 weeks after the end of all study therapy. Levels of HCV RNA will be determined with the Roche COBAS® AmpliPrep/COBAS® TaqMan® HCV Test, v2.0, which has a LLoQ of 15 IU/mL.
Time frame: Week 36 (24 weeks after completing study therapy)
Emergence of viral resistance-associated variants (RAVs)
The RAVs resistant to EBR or GZR, including the association of baseline RAVs with treatment outcomes (SVR12 and SVR24) and the emergence of RAVs in participants who fail to achieve SVR will be determined.
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Time frame: Up to 12 weeks